Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

June 30, 2011

Study Completion Date

September 30, 2015

Conditions
Unresectable Adenocarcinoma of the EsophagusMetastatic Adenocarcinoma of the EsophagusUnresectable Adenocarcinoma of Gastric CardiaMetastatic Adenocarcinoma of Gastric Cardia
Interventions
DRUG

FOLFOX

Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions

DRUG

5-FU

5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.

DRUG

Erlotinib

All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.

Trial Locations (2)

90095

Translational Oncology Research International (TORI) Network, Los Angeles

UCLA Jonsson Comprehensive Cancer Center, Los Angeles

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

collaborator

Sanofi

INDUSTRY

collaborator

OSI Pharmaceuticals

INDUSTRY

lead

Translational Oncology Research International

OTHER